Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma

Bel, Elisabeth H.; Wenzel, Sally E.; Thompson, Philip J.; Prazma, Charlene M.; Keene, Oliver N.; Yancey, Steven W.; Ortega, Héctor; Pavord, Ian D.

doi:10.1056/nejmoa1403291

Cited by 1,397 publications

(1,260 citation statements)

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“…The systematic literature search identified four randomised controlled trials which examined the efficacy of mepolizumab [22–25], and five trials (published in four papers) which examined the efficacy of reslizumab [26–28]. All studies had placebo as comparator.…”

Section: Resultsmentioning

confidence: 99%

“…In the subsequent paragraphs, we have named study 1 Castro 2015a , and study 2 Castro 2015b . The study by Bel et al [25] was not included in the meta-analysis because the study design differed significantly from the other studies. The results from Bel et al were instead described for each outcome.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies were included comprising 884 patients [22,24,25]. The relative improvement was 1.58 (95% CI 1.33; 1.87) on the percentage of patients experiencing 0 exacerbations in favour of the anti-IL-5 group.…”

Section: Resultsmentioning

confidence: 99%

“…A single randomised study ( n = 135) of mepolizumab was included for further analysis [25], which showed a median reduction of OCS of 50% (95% CI 20; 75) compared to a 0% (95% CI −20; 33.3) reduction in the placebo group. Due to the lack of statistical evaluation of the average reduction in OCS between mepolizumab and placebo, it was not possible to assess the predefined MCID of 20%.…”

Section: Resultsmentioning

confidence: 99%

“…Nine randomised trials of 3160 patients were included in the meta-analysis (four regarding mepolizumab [22–25], and five regarding reslizumab [26–29]). No studies presented the number of patients experiencing the MCID of 200 mL in forced expiratory volume (FEV1).…”

Section: Resultsmentioning

confidence: 99%

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Efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab anti-IL-5 treatments of severe asthma – a systematic review and meta-analysis

Henriksen

Bødtger

Sidenius³

et al. 2018

European Clinical Respiratory Journal

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Background: New, complex, and expensive therapies targeting Interleukin-5 (IL-5) to treat severe eosinophilic asthma are emerging.Objective: To assess efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab for treating severe eosinophilic asthma.Design: A systematic review and meta-analysis on randomized, placebo-controlled, clinical trials elucidating two critical (exacerbation rate and oral corticosteroid (OCS) use) and six important clinical outcomes on the efficacy and safety of mepolizumab and reslizumab.Results: Five studies (N = 2197) contributed with data for exacerbation rate, showing a reduction of 53% (95% CI 46; 59) in favour of anti-IL-5, corresponding to –0.94 annual exacerbations (95% CI –1.08;–0.82), thus exceeding the predefined minimal clinical important difference (MCID) of 25% reduction of the estimated ≥2 annual exacerbations. Quality of evidence was considered moderate, with low heterogeneity in study findings (I2 = 0%). One study (N = 135) contributed with data on percentage of patients experiencing ≥50% reduction inoral corticosteroid treatment, showing an effect of 20% (95% CI 2.3;47) in favour of anti-IL-5 treatment (mepolizumab), thus exceeding the predefined MCID of 10%. Quality of evidence was considered low.Compared to placebo, anti-IL-5 showed significant improvements in lung function, asthma control, and asthma-related quality of life, but below the MCIDs. No differences were observed for serious adverse events and number of patients, who dropped out. No studies evaluating sickleave or head-to-head comparisons were identified. By indirect comparison, we found no significant difference between mepolizumab and reslizumab in any ofthe predefined clinical outcomes. OCS treatment reduction could not be compared due to lack of reslizumab studies investigating this outcome.Conclusions: Mepolizumab and reslizumab provide significant and clinically relevant improvements in exacerbation rate and OCS reduction. Indirect, inter-study comparisons revealed no differences between the anti-IL-5 drugs in efficacy or safety measures.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab anti-IL-5 treatments of severe asthma – a systematic review and meta-analysis

Henriksen

Bødtger

Sidenius³

et al. 2018

European Clinical Respiratory Journal

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Diagnosis and Management of Asthma in Adults

McCracken

Veeranki

Ameredes

et al. 2017

JAMA

172

154

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Asthma is characterized by variable airway obstruction, airway hyperresponsiveness, and airway inflammation. Management of persistent asthma requires avoidance of aggravating environmental factors, use of short-acting β2-agonists for rapid relief of symptoms, and daily use of inhaled corticosteroids. Other controller medications, such as long-acting bronchodilators and biologics, may be required in moderate and severe asthma. Patients with severe asthma generally benefit from consultation with an asthma specialist for consideration of additional treatment, including injectable biologic agents.

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Mepolizumab versus placebo for asthma

Powell

Milan

Dwan

et al. 2015

Cochrane Database of Systematic Reviews

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It is not possible to draw firm conclusions from this review with respect to the role of mepolizumab in patients with asthma. Our confidence in the results of this review are limited by the fact that the intravenous route is not currently licensed for mepolizumab, and the evidence for the currently licenced subcutaneous route is limited to a single study in participants with severe eosinophilic asthma.The currently available studies provide evidence that mepolizumab can lead to an improvement in health-related quality of life scores and reduce asthma exacerbations in people with severe eosinophilic asthma.Further research is needed to clarify which subgroups of patients with asthma could potentially benefit from this treatment. Dosage, ideal dosing regimens and duration of treatment need to be clarified, as the studies included in this review differed in their protocols. There are no studies reporting results from children, so we cannot comment on treatment for this age group. At the present time, larger studies using licenced treatment regimens are required to establish the role of mepolizumab in the treatment of severe asthma.

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Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma

Abstract: In patients requiring daily oral glucocorticoid therapy to maintain asthma control, mepolizumab had a significant glucocorticoid-sparing effect, reduced exacerbations, and improved control of asthma symptoms. (Funded by GlaxoSmithKline; SIRIUS ClinicalTrials.gov number, NCT01691508.).

Cited by 1,397 publications

References 21 publications

Efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab anti-IL-5 treatments of severe asthma – a systematic review and meta-analysis

Efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab anti-IL-5 treatments of severe asthma – a systematic review and meta-analysis

Diagnosis and Management of Asthma in Adults

Mepolizumab versus placebo for asthma

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